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ISRCTN
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ISRCTN78953383
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ClinicalTrials.gov identifier
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Public title
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Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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G31
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ovarian Cancer
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Participants - inclusion criteria
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1. Confirmed diagnosis of invasive epithelial ovarian carcinoma including the following histological subtypes: Serous cystadenocarcinoma; Mucinous cystadenocarcinoma; Endometriod carcinoma; Clear cell (mesonephroid) carcinoma; Undifferentiated carcinoma
2. International Federation of Gynecology and Obstetrics (FIGO) stage Ic, II, III and IV
3. Age 18 -70 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Life expectancy of at least 3 months
6. Adequate bone marrow and renal function
7. No previous chemotherapy or radiotherapy
8. No history of previous malignancy, except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
9. No serious intercurrent disease
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/01/1991
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Anticipated end date
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01/03/1991
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Group A: Cisplatin 50 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles
2. Group B: Cisplatin 100 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK (CRUK) (UK)
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Trial website
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Publications
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1992 results in http://www.ncbi.nlm.nih.gov/pubmed/1353804
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 207 670 4723
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Fax
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+44 (0) 207 670 4818
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Email
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)207 317 5186
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Fax
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+44 (0)207 487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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02/02/2012
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Date ISRCTN assigned
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01/07/2001
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